857 Titrando The intelligent all-rounder with ... - Lambda-Med Kft.

Quality and compatibility
Compatibility and traceability
GLP, GMP, 21 CFR Part 11 are becoming increasingly important in day-to-day laboratory life. The
Titrando System is entirely oriented towards quality management in the laboratory and offers the
following possibilities:
• Each time that it is switched on the Titrando System carries out a self-diagnosis.
• If it has been programmed accordingly then the instrument will remind you about any validation
or service work that is due.
• You can enter limits for results; their observance will be checked for each determination.
• The titer of the titrant can be monitored as a function of time in both tabular form or as a graph,
similar to a control card.
• The calibration history of the sensors can be called up. This means, for example, that alterations
to the sensor caused by aging can be recognized before they affect the results.
• All changes to the methods are documented; traceability is guaranteed.
The Titrando allows strict control of rights of access using login and password. The requirements
defined in FDA Regulation 21 CFR Part 11 regarding «electronic signature» and «electronic record»
are fulfilled in the stand-alone system using Touch Control as well as in the version controlled via PC.
This also applies to the other points contained in this regulation, namely the protection of electronic
records against accidental or intentional alteration and the complete traceability. The Titrando with
Touch Control is the only stand-alone titration system with Audit Trail.
Quality management at Metrohm
Quality has always been extremely important for Metrohm. On 5 November 1993 our company
achieved the ISO 9001 certificate of quality. The Metrohm quality management system is continually
being perfected and checked by both internal and external audits.
The Titrando System is modern. This also applies to the object-oriented development system used in
its creation. The Touch Control as a color display and operational element is unique, as are the many
other innovations of the Titrando System.
16